Flap Vs Flapless Technique for Delayed Implant Placement in the Maxillary Esthetic Zone

NCT07654452 | Completed

• 1 other identifier: 970/2025
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized comparative clinical trial aims to evaluate the clinical, radiographic, and esthetic outcomes of flap versus flapless techniques for delayed dental implant placement in the maxillary esthetic zone. Sixteen patients requiring implant placement in the maxillary anterior or premolar region will be randomly allocated into two equal groups. Group I will undergo implant placement using the conventional flap technique, while Group II will receive implant placement using the flapless technique. Clinical outcomes including postoperative pain, edema, surgical insertion time, and implant stability will be assessed. Radiographic evaluation will include peri-implant bone quantity, bone quality, and crestal bone loss. Follow-up examinations will be performed immediately after surgery and at 1, 3 and 6 months postoperatively.

Conditions

Dental Implant; Tooth Loss; Partial Edentulism; Maxillary Tooth Loss

Keywords

Dental Implant; Flapless Implant Surgery; Flap Technique; Dental Implant Stability; Marginal Bone Loss

Outcome Measures

Primary Outcomes (3)

• Implant Stability Quotient (ISQ)

  Implant stability measured using the Osstell resonance frequency analysis device.

  Immediately after implant placement and 6 months postoperatively.

• Marginal Crestal Bone Loss

  Radiographic assessment of peri-implant crestal bone level changes using standardized digital periapical radiographs.

  Immediately postoperative, 1 month, 3 months, and 6 months.

• Relative bone density

  Radiographic assessment of peri-implant bone density using standardized digital periapical radiographs.

  Immediately postoperative, 1 month, 3 months, and 6 months.

Secondary Outcomes (4)

• Postoperative Pain

  Postoperative days 1, 3, and 7.

• Postoperative Edema

  Postoperative days 1,3 and 7.

• Surgical Insertion Time

  During surgery.

• Postoperative Comfort

  1 day postoperatively

Study Arms (2)

Flap Technique

EXPERIMENTAL

Delayed implant placement using a conventional full-thickness mucoperiosteal flap approach.

Procedure: Flap Implant Placement

Flapless Technique

EXPERIMENTAL

Delayed implant placement using a flapless surgical approach.

Procedure: Flapless Implant Placement

Interventions

Flap Implant Placement PROCEDURE

Implant placement following crestal incision and mucoperiosteal flap elevation to expose the alveolar ridge.

Flap Technique

Flapless Implant Placement PROCEDURE

Implant placement performed without flap elevation using a minimally invasive flapless approach.

Flapless Technique

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged from 30 to 50 years old.
• Adults of both genders.
• Patients who are free from any systemic disease (ASA I).
• Patients with teeth loss at upper anterior and premolar regions more than 1-year.
• Presence of sufficient apical and peripheral bone to achieve primary implant stability (minimum 3-5 mm of bone beyond the socket apex and overall socket length ≥ 10 mm).
• Patients with bone quality classified as D3, as assessed by pre-operative CBCT.

You may not qualify if:

• Pregnant and lactating women.
• Heavy smoking (\>10 cigarettes/day)
• Patients with bad oral habits such as bruxism.
• Patients with poor oral hygiene.
• Patients with gingival diseases.
• Patients with periodontal diseases (with severe vertical or horizontal bone loss).
• Teeth with periapical or lateral infection or lesions.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University, Faculty of Dentistry

Ismailia, Egypt

Location

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Mohamed Said Hamed, Professor of Oral and Maxillof

  Suez Canal University

  STUDY CHAIR

• Ahmed Abdelmohsen Younis, Associate Professor of Oral an

  Suez Canal University

  STUDY DIRECTOR

• Mina Raafat, B.S.D

  Suez Canal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned into two parallel groups. One group will receive delayed implant placement using the conventional flap technique, while the second group will receive delayed implant placement using the flapless technique.

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: January 10, 2025
• Primary Completion: April 10, 2026
• Study Completion: May 10, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

EG (1)